Read this Introduction to ISO 14971:2019 to learn more about:

  • Key terms related to MedTech risk management
  • The risk management process outlined by ISO 14971
  • Risk management vs design control

With patient and operator safety being a top concern, innovators of medical devices need to make sure their products are reliable and safe to use. That’s what risk management helps ensure – which is why regulators worked out ISO 14971, a standard containing guidance on the application of risk management to medical devices.

Besides being mandatory, ISO 14971 is a powerful tool to efficiently manufacture safer and higher quality medical devices. Therefore, a thorough understanding of the standard is of fundamental importance to all MedTech developers.

Download our guide to ISO 14971 for key MedTech risk management insights! Understand the scope and benefits of ISO 14971, as well as the risk management process that the standard outlines.


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